Summary
The Canadian Intellectual Property Office (CIPO) has now released Practice Notice PN 2015-01, which relates to examination of medical treatment claims. The Practice Notice softens some of the current examination guidelines on the patentability of dosage regimens. In this new guidance, essential claim elements which relate to a fixed dosage, a fixed dosage regimen, a patient sub-population, or to an administration site are now identified as elements which are not considered to limit a physician's professional skill or judgment, an important factor in determining subject matter eligibility.
Introduction
On March 18, 2015, the Canadian Intellectual Property Office (CIPO) released Practice Notice PN 2015-01 - "Revised Examination Practice Respecting Medical Uses", which revises previous Practice Notice PN 2013-04 (June, 2013;) regarding the examination of medical and surgical method claims in Canada. PN 2015-01 is intended to update CIPO's examination practice concerning medical use claims following a recent Federal Court decision in AbbVie Biotechnology Ltd. v. The Attorney General of Canada, 2014 FC 1251 ("AbbVie").
The updated Practice Notice softens examination guidelines concerning the patentability of medical use claims, particularly claims to dosage regimens. While it remains to be seen exactly how CIPO will implement this guidance moving forward, the revisions strongly imply that fixed dosage regimens will not be automatically considered impermissible subject matter so long as the essential elements of the claims do not prevent, interfere with, or require the professional skill of a physician.
Revised Practice Notice PN 2015-01 and Methods of Medical Treatment
In Canada, medical use claims are generally considered patent-eligible subject matter, whereas methods of medical treatment are not. The revised notice maintains that inventions which prevent physicians "from exercising their skill and judgment in using a known compound for an established purpose" cover a method of medical treatment and therefore are non-statutory subject matter; however, additional guidance is now provided regarding whether or not essential claim elements relating to dosage regimens should be interpreted as skill- or judgment-limiting to the physician.
The previous Practice Notice (PN 2013-04) noted that:
"if, however, it is determined after a purposive construction that a dosage regimen or dosage range is an essential element of a claim encompassing the use of a known compound in an established treatment, then the claim covers a method of medical treatment, and thus, is not compliant with section 2 of the Patent Act".
This statement has been softened in the revised Practice Notice, which now indicates that:
"if it is determined after a purposive construction that a dosage range, or dosage regimen that includes a range, is an essential element of a claim encompassing the use of a known compound in an established treatment, then the claim may cover a method of medical treatment". (emphasis added)
As well, the previous Practice Notice PN 2013-04 indicated that:
"where an essential element only serves to instruct a medical professional "how" to treat a patient, rather than "what" to use to treat the patient, this will lead to the conclusion that the claimed use encompasses a method of medical treatment".
The revised Practice Notice has been updated to clarify that:
"where an essential element only serves to instruct a medical professional "how" to treat a patient, rather than "what" to use to treat the patient, it must be determined whether the essential element prevents, interferes with or requires the professional skill of a physician. If the answer is "yes", this will lead to the conclusion that the claimed use encompasses a method of medical treatment that does not comply with section 2 of the Patent Act". (emphasis added)
One of the most important revisions in PN 2015-01 appears in the section of PN 2013-04 which elaborates on examples of essential claim elements which limit a physician's professional skill or judgment. PN 2013-04 recited that:
"essential elements that point to a limitation of a physician's professional skill or judgment include those that provide details of a dosing schedule, those that represent a range of potential dosages that a patient may receive (as distinct from a range of dosage forms), and those that narrow treatment to a patient sub-population (rather than bring treatment to a new population) or administration site".
The revised section, however, now recites that:
"essential elements that point to a limitation of a physician's professional skill or judgment include those that provide details of a dosing schedule encompassing a range and those that represent a range of potential dosages that a patient may receive (as distinct from a range of dosage forms). In contrast, essential elements that narrow treatment to a fixed dosage, a fixed dosage regimen, a patient sub-population or to a particular administration site are not considered to point to a limitation of a physician's professional skill or judgment".
These amendments should guide patent Examiners away from issuing objections to claims encompassing dosage regimens without first considering how the claims relate to the physician's professional skill and judgment. Importantly, claims which encompass a fixed dosage or dosage regimen, as opposed to a dosage or dosage regimen range, appear to be specifically identified as patent-eligible subject matter. Indeed, in AbbVie, it was noted at paragraph 114 that "... a claim which does not restrict, or interfere with, or otherwise engage professional skill or judgment - including a claim for a fixed dosage and or a fixed dosage schedule or interval - is not impermissible subject matter where there is no evidence to contradict that claimed dosage".
Furthermore, the revised Practice Notice now specifies that essential claim elements which narrow treatment to a patient sub-population or to a particular administration site are no longer considered to limit a physician's professional skill or judgment. These revisions should be of particular interest to those operating in the personalized medicine field, where the identification of patient sub-populations may often be of special importance.
Conclusions
Revised Practice Notice PN 2015-01 will come as a welcome change for many companies operating in the life sciences area. While methods of medical treatment remain outside the scope of "invention", this revised Practice Notice opens the possibility for claims encompassing inventions which include fixed dosage regimens, patient sub-populations, or particular administration sites as essential elements, so long as they do not prevent, interfere with or require the professional skill of a physician. Generally speaking, CIPO has long viewed claims concerning "what" to use for treatment (i.e. compounds or compositions) as patent eligible. With this revision, it appears CIPO is now also willing to consider claims concerning "how" to treat a patient, so long as the physician's skill and judgment is not engaged.
It remains to be seen how CIPO will implement the guidance provided in PN 2015-01 moving forward. The revised Practice Notice maintains that dosage regimens encompassing ranges rather than a fixed dosage or interval are still likely to be considered as methods of medical treatment by CIPO and therefore unpatentable subject matter. However, these recent developments indicate a softening of CIPO's position concerning the patentability of dosage regimens, and will likely come as a welcome shift in perspective for many in the pharmaceutical industry.